Human Subjects
The Human Subjects Committee (also known as the Institutional Review Board or IRB) assures that risks to human research subjects are minimized, consent is voluntary and informed and confidentiality is protected. The committee upholds the principles articulated in the Belmont Report and applies the regulations articulated in the Common Rule.
Cayuse IRB
Effective March 1, 2024, SDSU researchers who want to submit an Institutional Review Board (IRB) application to the SDSU IRB for review, click on the link below in the blue box to access SDSU Cayuse Human Ethics.
To access SDSU Cayuse Human Ethics, you need an SDSU email address.
Request Cayuse User Access
If you don’t have access to the SDSU Cayuse, click on the link below in the blue box to submit a request form for user access. You need an SDSU email address for this.
Amendment to the existing applications
If your research application is already approved in InfoReady and is still valid, you DO NOT need to submit a new application in Cayuse.
However, if your research application in InfoReady is expiring and needs an extension or amendment, you still need to submit a new Initial application in Cayuse at least two weeks before the expiration date.
The human subjects research records in InfoReady Will Not be transferred to Cayuse. To review your application, IRB reviewers need to review the full information to determine if your application can be approved.
Determine if you need an IRB Review:
To determine if your study, research or project requires Committee review, submit a request via Cayuse by logging into Cayuse Human Ethics. The IRB Administrator will review the request to determine if the activity meets the definitions of ‘research’ and ‘human subjects’.
Once the IRB Administrator makes the determination, the determination form will be sent back to the requestor as official documentation.
Cayuse IRB Training and Assistance
If you have not yet watched the recorded Cayuse Human Ethics Training Sessions, please do so:
- For investigators: How to create and submit IRB applications
- For department heads: How to approve IRB applications
Below are the step-by-step instructions for
- Read Step-by-Step Help Guidance on Tutorial for Submitting an Application for review by the SDSU IRB in Cayuse
- Read Step-by-Step Help Guidance on Tutorial for Department Chair Approval of an IRB Application in Cayuse
- Read Step-by-Step Help Guidance on Tutorial for a Modification for review by the SDSU IRB in Cayuse
*Renewal or Modification can be submitted only if the initial IRB application was approved in Cayuse. For all Renewals and Modifications to the initial IRB applications that were previously approved in InfoReady, please submit a New (Initial) Application/Protocol in Cayuse.
Training
All researchers conducting human subjects research are required to complete training in the protection of human research participants via CITI Training. Review the CITI Training FAQs for any questions.
Email the Institutional Review Board (IRB)
Report a problem
Researchers must report any incident that is unexpected (given the research procedures and population), may have been caused by the procedures involved in the research and suggests that the research places subjects or others at a greater risk of harm (including physical, psychological, economic or social harm) than was previously known or recognized. In addition to adverse events/effects, you should also report any breaches of confidentiality and complaints about the study from subjects or staff.
If any such problem occurs, please take the following action:
- Attend to the safety and care of the research participant(s).
- Consider whether any more participants should be used in the research and consider immediately stopping the study until the occurrence is investigated.
- If the problem is serious (harmful, fatal or life threatening), report the event either orally or in writing to the Research Integrity and Compliance Officer within three days or call 605-688-5642.
For all problems, submit the Incident-Complaint form through SDState InfoReady within 10 working days. The Research Integrity and Compliance Officer will review the report to follow up and take appropriate action.
